Adapted physical activity program for women during active breast cancer treatment
Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer During the Active Phase of Treatment: a Randomized Controlled Trial
This program will test whether a standardized adapted physical activity program for women undergoing active breast cancer treatment improves quality of life and lowers healthcare costs compared with usual activity recommendations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 866 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05949983 on ClinicalTrials.gov |
What this trial studies
This interventional project compares a standardized adapted physical activity (APA) program to conventional management based on simple physical activity recommendations for women receiving surgery, chemotherapy, radiotherapy, and/or hormone therapy. Eligible participants are women medically able to take part in exercise who are treated at the coordinating center and will be assigned to the APA program or to conventional management. The study will collect patient-reported quality of life, symptoms and treatment side effects, and health care resource use to quantify costs associated with each approach. Health economic analyses will compare costs and effectiveness to determine the value of offering a structured APA program during the active treatment phase.
Who should consider this trial
Good fit: Women of any breast cancer type or stage who are currently receiving surgery, chemotherapy, radiotherapy, or hormone therapy and who have no medical contraindication to exercise are ideal candidates.
Not a fit: Patients with severe cardiac, respiratory, infectious, hematologic, or recent surgical complications, uncontrolled serious comorbidities, symptomatic bone metastases, or other contraindications to exercise are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this program could improve patients' quality of life during treatment and reduce overall healthcare costs, supporting wider access to adapted physical activity.
How similar studies have performed: Meta-analyses and prior studies after adjuvant therapy have shown benefits of adapted physical activity on quality of life and mortality, but economic evaluations and trials during active treatment are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women with breast cancer * any type of breast cancer, all grades, all stages * during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy Exclusion Criteria: * World Health Organization (WHO) 4 * Unstable angina * Uncontrolled Atrial fibrillation * Uncontrolled high blood pressure * Recent myocardial infarction or myocarditis or pericarditis or thromboembolic disease (less than 3 weeks) * Aortic stenosis or valve disease to operate * Cardiac or respiratory failure, with dyspnea at rest * Symptomatic anemia, thrombocytopenia * Lytic or painful bone metastases, Severe osteoporosis * Severe infectious syndrome, * Surgery in the last 3 weeks * Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, severe undernutrition * Contraindication to the practice of an adapted physical activity programme * Currently involved or exclusion period of a interventional study or adapted Physical Activity program * Patient with protective measures (guardianship, curators, and deprivation of liberty). * Pregnancy or breastfeeding * Patient with severe functional limitations
Where this trial is running
Toulouse
- Marie-Eve Rougé-Bugat — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Marie-Eve Rougé-Bugat, MD — University Toulouse
- Study coordinator: Marie-Eve Rougé-Bugat, MD
- Email: marieeve.rouge-bugat@dumg-toulouse.fr
- Phone: 5 61 80 01 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.